Kornimate/medical-research-clean huggingface dataset:
induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone

Conditions: Opioid-related Disorders

Summary: the purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. the primary outcome measure is the severity of withdrawal symptoms measured using the clinical opiate withdrawal scale (cows). the primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as subutex and suboxone sublingual tablets in the treatment of opioid dependence. however, only films administered by the sublingual route were evaluated in this study. the soluble film dosage is expected to provide the following enhancements and potential advantages over the current subutex and suboxone product: * mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * improvement in subject convenience and compliance by ensuring rapid disintegration. * protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. this provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * provision of a unit dose product format for hospital and institutional use. * decreased product damage during shipping as compared to subutex and suboxone tablets.

Eligibility criteria:
inclusion criteria: subject must: * provide written informed consent. * have a diagnostic and statistical manual of mental disorders-iv (dsm-iv) diagnosis of opioid dependence. * be male or female, 18 to 65 years of age, inclusive. * if female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control. exclusion criteria: subjects must not: * have participated in an experimental drug or device study within the last 30 days. * be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment. * if female, be breast feeding or lactating. * have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study. * have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia). * have current suicidal ideation. * have a mini mental status exam score less than 24. * have physical dependence on alcohol. * have physical dependence on sedative-hypnotics. * have active aphthous stomatitis. * have active oral herpes. * need on-going prescription medications that interact with the p450 3a4 (a member of the cytochrome p450 superfamily of enzymes) system.

Keywords: opioid dependence opioid withdrawal symptoms
pupillometry guided remifentanil administration and total opioid consumption during propofol - remifentanil tci

Conditions: Pain

Summary: the aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. all patients were anesthetized with tci of propofol and remifentanil. in the intervention group, peroperative remifentanil target was guided by pupillometry. in the other group, remifentanil was administered according to standard practice.


Eligibility criteria:
inclusion criteria: * asa i-ii * elective gynecological surgery * no ophtalmologic or neurologic disease * no chronic analgesic medication * expected length of surgery 60 minutes minimum exclusion criteria: * ophtalmologic or neurologic disease * chronic analgesic medication
endoscopic treatment of recurrent upper gi bleeding: otsc [over the scope clip] versus standard therapy

Conditions: Acute Upper Gastrointestinal Hemorrhage

Summary: prospective-randomized trial. patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the otsc \[over the scope clip\] or endoscopic standard therapy. hypothesis: endoscopic therapy with otsc is superior to standard therapy regarding technical success and rebleeding.


Eligibility criteria:
inclusion criteria: * recurrence of bleeding from gastroduodenal ulcers exclusion criteria: * malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with otsc

Keywords: otsc upper gastrointestinal bleeding
outcome study of lanthanum carbonate compared with calcium carbonate in hemodialysis patients : landmark study

Conditions: Hemodialysis; Hyperphosphatemia

Summary: the purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in japanese hemodialysis patients treated with lanthanum carbonate compared with those with calcium carbonate.

elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. a recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. a post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.

Eligibility criteria:
inclusion criteria: * hemodialysis patients with hyperphosphatemia who require phosphate binders * hemodialysis for more than 3 months * patients who have at least one calcification risk factor (elderly \> 65 years, postmenopausal woman, type 2 diabetes mellitus) * intact-pth \< or = 240pg/ml * life expectancy \> 1 year * with written informed consent exclusion criteria: * contraindications to lanthanum carbonate and calcium carbonate * swallowing disorders * severe gi disorders * history of obstructed bowels * history of ihd/stroke within 6 months before randomization * nyha classification ⅲ-ⅳ * severe liver dysfunction (ast or alt greater than 3 times the upper limit of institution * require treatment of arrhythmia * severe malnutrition * malignancy of any type within the last five years * peritoneal dialysis patients * pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term * ineligible patients according to the investigator's judgment

Keywords: ckd-mbd phosphate-binder vascular calcification mortality dialysis hemodialysis patients with hyperphosphatemia
novel lenses for myopia progression trial

Conditions: Myopia, Progressive

Summary: this is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to single-vision spectacles. a total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. at the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. myopia progression during the second year with test lenses will be compared to historical or published controls.


Eligibility criteria:
inclusion criteria: be accompanied by a parent or guardian who is able to read and comprehend chinese/english and sign a record of informed consent/assent; at baseline, be within the age range of 7 to 13 years old inclusive; be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (d) and -5.00 dioptre (d); astigmatism ≤1.50d; anisometropia of not more than 1.50d; be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; have ocular findings deemed to be normal; vision correctable to at least 0.8 or better in each eye with spectacles. exclusion criteria: any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; any systemic disease that adversely affects ocular health e.g. diabetes, graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, sjögrens syndrome and systemic lupus erythematosus. conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial. history of eye trauma amblyopia strabismus history of use of myopia control interventions such as orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial. known allergy or intolerance to ingredients to cycloplegic eye-drops. currently enrolled in another clinical trial.
thoraflex hybrid and relay extension post-approval study

Conditions: Thoracic Diseases; Aortic Aneurysm; Aortic Dissection; Thoracic Aortic Aneurysm; Thoracic Aortic Dissection

Summary: the goal of this observational study is to evaluate the thoraflex hybrid device alone and in combination with the relaypro nbs stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. patients who undergo treatment with the thoraflex hybrid device with or without extension with a relaypro nbs stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. participant involvement in the study will last for a total of 10 years from the point at which the thoraflex hybrid device is placed.


Eligibility criteria:
inclusion criteria: patient is aged 18 years or older on date of consent. patient is willing and able to comply with all study procedures and visits. patient or their next of kin (nok)/legally designated representative (ldr) has given written informed consent to participate in the study. patient will undergo treatment with a thoraflex hybrid device. if a patient requires an extension procedure due to the extent of aortic disease, a relaypro nbs stent-graft should be placed inside the distal end of the previously placed thoraflex hybrid device via a retrograde approach. this may be part of the same or a two-stage procedure. exclusion criteria: * patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.

Keywords: tevar frozen elephant trunk (fet)
chromosome 9 p minus syndrome

Conditions: Chromosome 9P Deletion Syndrome; 9p Minus Syndrome; Alfi Syndrome; 9P Monosomy; 9P Partial Monosomy Syndrome

Summary: patients with deletion of chromosome 9 p are rare (\~200 in the medical literature) and have a diverse set of phenotypic characteristics. we propose using state of the art genome sequencing methods to define the location and size of the deleted portion of chromosome 9 p as well as the genetic background in affected patients (whole genome sequencing) and correlate the genes in the deleted portion of chromosome 9 p with specific phenotypic characteristics of each patient. enrolled participants will be asked to complete a detailed questionnaire, complete a medical release form, and provide a biospecimen sample.


Eligibility criteria:
inclusion criteria: * having 9p minus syndrome/ deletions on the 9th chromosome * parents and siblings of affected individuals may also be included to determine contribution of genetic background to phenotypic characteristics exclusion criteria: * no exclusion criteria for either affected individuals or their parents or siblings.
are newborns conscious of the placebo effect? result from an rct in osteopathy

Conditions: Prematurity

Summary: results from previous studies suggest the association between osteopathic manipulative treatment (omt) and length of stay (los) reduction in a population of preterm infants. the primary objective of the present study is to evaluate the effectiveness of sham omt in reducing los in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.


Eligibility criteria:
inclusion criteria: * preterm infants born at age between 29 and 37 weeks * sham osteopathic treatment performed \< 14 days after birth * preterm infants born in the same hospital exclusion criteria: * gestational age \ 37 weeks; * sham osteopathic treatment performed \> 14 days after birth; * newborn transferred to/from other hospital; * newborn from to hiv seropositive and/or drug addict mother; * newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.
vitamin e and n-acetylcysteine for preventing contrast-induced acute kidney injury after coronary artery catheterization

Conditions: Coronary Artery Disease; Coronary Artery Angiography; Coronary Catheterization; Contrast-induced Nephropathy; Stable Angina; Acute Coronary Syndrome

Summary: in a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. the aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (ciaki).

patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. patients will be randomly assigned into three groups in a 1:1:1 ratio (computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. the participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold. all patients will be entered into three group and they will be given normal saline 0.9%, vitamin e, nac, and the placebos of both regimens. the vitamin e will be given as a soft gel capsule and its placebo will have the same shape and taste. the nac will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. these drugs will be given in addition to the routine hydration therapy which will be given to all patients. primary outcome will be the development of ciaki. secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the ciaki within 48-72 hours after intervention.

Eligibility criteria:
inclusion criteria: patients aged ≥18 years with baseline estimated glomerular filtration rate (egfr) \<60 ml/min per 1.73 m2 (based on the modification of diet in renal disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention \[pci\]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-st-segment elevation (nste) acute coronary syndrome (acs) requiring an early invasive strategy, and patients undergoing elective pci . exclusion criteria: acute st-segment elevation myocardial infarction, high-risk nste-acs warranting emergency coronary angiography (\<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction \<30%, acs undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, aki, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin e, vitamin c, or n-acetylcysteine (nac) at least 48 hours before intervention.
the emotion builder: an intervention for emotional deficits after brain injury

Conditions: Traumatic Brain Injury; Alexithymia

Summary: the purpose of this study is to examine a web-based training program for treating emotional problems in people who have suffered a traumatic brain injury (tbi).

this is a pilot study to examine how subjects with tbi feel about the virtual reality program as a treatment and to assess the effectiveness of the virtual reality program at increasing subjects' awareness and understanding of emotions.

Eligibility criteria:
inclusion criteria: * tbi (injury due to an external physical force); * moderate to severe tbi, defined either by74 glasgow coma score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes); * ≥1 year post-injury; * between 18-65 years old; * have a moderate to high alexithymia score (≥52) on the tas-2070 at screening. exclusion criteria: * diagnosed with pre-morbid neurological disorders (e.g. stroke, autism, alzheimer's disease, parkinson's disease); * formerly diagnosed with a developmental disability; * pre-morbid diagnosis of major psychiatric disorders (e.g. schizophrenia); * unable to follow directions; * uncorrected visual or hearing impairments that would prevent sufficient task participation; * no access to reliable transportation.

Keywords: traumatic brain injury alexithymia emotions
a non interventional study with oxaliplatin onkovis (oxaliplatin) utilized for the treatment of cancer

Conditions: Carcinoma

Summary: the main purpose of this observational study with oxaliplatin onkovis is to determine the number of treatment cycles and the quantity of oxaliplatin onkovis needed for this purpose under the special circumstances of ambulant chemotherapy. onkovis aims to contribute to an economical utilization of the chemotherapeutics. this includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective. secondary objective is the assessment of the side effects of oxaliplatin onkovis. to this end, data regarding co-medication and adverse events are also collected.


Eligibility criteria:
inclusion criteria: * indication for oxaliplatin according to the summary of product characteristics (smpc) and treating physician exclusion criteria: * according to the oxaliplatin smpc

Keywords: carcinoma colon cancer colorectal cancer ambulant chemotherapy treatment cycles oxaliplatin oxaliplatin onkovis quantity of oxaliplatin packaging sizes
relative bioavailability of oral suspension of rivaroxaban compared to standard tablet

Conditions: Biological Availability

Summary: rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders. thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. as small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight. the objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a rivaroxaban oral solution with that of the rivaroxaban tablet approved for treatment. in order to evaluate the potential influence of food, the oral suspension containing 20 mg rivaroxaban will be taken after consuming food. in addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.


Eligibility criteria:
inclusion criteria: * healthy male subjects * age: 18 to 55 years (inclusive) at the first screening examination exclusion criteria: * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * known coagulation disorders (eg von willebrand's disease, hemophilia) * known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer) * known sensitivity to common causes of bleeding (eg nasal) * regular use of medicines * clinically relevant findings in the ecg (electrocardiogram) such as a second- or third-degree av block, prolongation of the qrs complex over 120 msec or of the qtc-interval over 450 msec * clinically relevant findings in the physical examination * clinically relevant deviations of the screened laboratory parameters from reference ranges * participation in another clinical study during the preceding 3 months (last treatment from previous study to first treatment of new study)

Keywords: relative bioavailability rivaroxaban
gefitinib in combination with chemoradiation in resectable gastric cancer

Conditions: Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC

Summary: to assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer


Eligibility criteria:
inclusion criteria: * histologically-confirmed intestinal gc (t2-t4) * local or locally advanced stage ii or stage iii gastric cancer of an upper part of the stomach or ge junction * lymph node positive or negative * metastasis negative * resection with curative intent (r0, d2) * chemo- and radiotherapy naïve * measurable lesion according recist * written informed consent exclusion criteria: * aged below 45 or over 70 * prior gastric surgery * active ild